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Therapeutic Durvalumab antibody from the original Imfinzi® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
PD-L1 |
Monoclonal Antibody |
Imfinzi® |
50 mg/mL |
– |
2 mg |
-80°C |
2021.10 |
190,80 € |
| Drug name | Imfinzi® |
| INN | Durvalumab |
| API type | Durvalumab is a human monoclonal IgG1κ antibody |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC28 |
| Target of antibody | PD-L1 Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1, Pdcd1lg1, Pdl1, RGD1566211 |
| General function | Durvalumab, is a monoclonal antibody, a type of protein designed to recognize and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells, produced in Chinese hamster Ovary (CHO) cells. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and 13 tumour-associated immune cells in the tumour microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production. Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation. |
| Original license holder | AstraZeneca |
| Marketing authorisation numbers | EU/1/18/1322/002 |
| Marketing authorisation holder | AstraZeneca AB SE-151 85 Södertälje Sweden |
| Name of the manufacturer of the biological active substance | AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland 21703 United States |
| Name and address of the manufacturer(s) responsible for batch release | MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom alternatively: MedImmune Pharma B.V. Lagelandseweg 78 6545CG Nijmegen, Netherlands |
| Max shelf life | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80 |
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